Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-10 @ 2:46 PM
Study NCT ID:
NCT00683202
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-03', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-22', 'studyFirstSubmitDate': '2008-05-21', 'studyFirstSubmitQcDate': '2008-05-22', 'lastUpdatePostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'Five weeks after embryo transfer'}], 'secondaryOutcomes': [{'measure': 'Uterine artery and spiral artery pulsatility index values', 'timeFrame': 'On the day of embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Assisted reproduction', 'Ovarian response', 'Uteroplacental hemodynamics', 'Doppler ultrasonography', 'Implantation rate', 'Pregnancy rate', 'Live birth rate'], 'conditions': ['Pregnancy', 'Miscarriage Less Than 12 Gestational Weeks', 'Extrauterine Pregnancy', 'Preeclampsia', 'Intrauterine Fetal Growth Restriction']}, 'referencesModule': {'references': [{'pmid': '20943705', 'type': 'DERIVED', 'citation': 'Haapsamo M, Martikainen H, Tinkanen H, Heinonen S, Nuojua-Huttunen S, Rasanen J. Low-dose aspirin therapy and hypertensive pregnancy complications in unselected IVF and ICSI patients: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2010 Dec;25(12):2972-7. doi: 10.1093/humrep/deq286. Epub 2010 Oct 13.'}, {'pmid': '19153091', 'type': 'DERIVED', 'citation': 'Haapsamo M, Martikainen H, Rasanen J. Low-dose aspirin and uterine haemodynamics on the day of embryo transfer in women undergoing IVF/ICSI: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2009 Apr;24(4):861-6. doi: 10.1093/humrep/den489. Epub 2009 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.', 'detailedDescription': 'Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have revealed conflicting results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\< 40 years\n* \\< 4 previous ovarian stimulations\n\nExclusion Criteria:\n\n* allergy for acetylsalicylic acid'}, 'identificationModule': {'nctId': 'NCT00683202', 'briefTitle': 'Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'The Significance of Low-Dose Aspirin on Ovarian Responsiveness, Uterine Hemodynamics and Pregnancy Outcome in in Vitro Fertilization and in Intracytoplasmic Sperm Injection: A Randomized, Placebo-Controlled Double-Blind Study', 'orgStudyIdInfo': {'id': '56/2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Acetylsalicylic acid 100 mg daily perorally', 'interventionNames': ['Drug: Acetylsalicylic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo daily perorally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['Low-dose aspirin'], 'description': 'Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'University Hospital of Oulu, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Mervi Haapsamo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Oulu, Finland'}, {'name': 'Juha Rasanen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA'}, {'name': 'Hannu Martikainen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Oulu, Finland'}, {'name': 'Juha S Tapanainen, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Oulu, Finland'}, {'name': 'Seppo Heinonen, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Kuopio, Finland'}, {'name': 'Helena Tinkanen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unversity Hospital of Tampere, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mervi Haapsamo/MD', 'oldOrganization': 'University Hospital of Oulu'}}}}